SECURE RELINE/PICKUP MATERIAL by IMTEC CORP.

The provided documents are a 510(k) clearance letter from the FDA for a device named "SECURE," which is an acrylic resin for relining dentures. This type of document typically does not contain detailed information about acceptance criteria or specific study designs, as it confirms substantial equivalence to a predicate device rather than de novo approval based on extensive clinical trial data.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not available in the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not specify performance metrics or acceptance criteria for the SECURE device nor does it report specific performance data from studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: The document does not describe any specific test set or studies that would involve sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Available: There is no mention of ground truth establishment or experts in the context of a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Available: No information on adjudication methods is present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable/Not Available: This device is an acrylic resin for dentures, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device type, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Available: As explained above, this is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Available: The document does not describe any studies that would involve establishing a ground truth for performance evaluation of the device.

8. The sample size for the training set

Not Available: No information about a training set is provided.

9. How the ground truth for the training set was established

Not Available: No information about a training set or its ground truth establishment is provided.

Summary:

The provided FDA 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device based on its intended use (as described in the "INDICATIONS FOR USE STATEMENT") and general safety and effectiveness. It does not contain the detailed study protocols, performance data, or statistical analysis that would typically be found in a clinical study report or a PMA submission for a novel device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2002

Mr. J. Brad Vance Director of Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K021586

Trade/Device Name: SECURE Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 08, 2002 Received: May 14, 2002

Dear Mr. Vance:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. J. Brad Vance

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Patina Circuit/fa

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

KO21586 510 (K) Number (if known):

SECURE Device Name:

Indications For Use:

SECURE is an acrylic resin used as a permanent hard relining / pickup material for complete and partial dentures.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or Over-The-Counter
Use
(Per 21 CFR 801.109)

Susa Runses
(Division Sign-Off)
Division of Dental, Infection Control,

Owision of Dental, Infection Control, and General Hospital Devic 12001: 510(k) Number

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.